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18F-DCFPyL PET-CT Scan and Prostate Cancer

Primary Purpose

Prostate Cancer Adenocarcinoma

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

18F-DCFPyL

About this trial

This is an interventional diagnostic trial for Prostate Cancer Adenocarcinoma focused on measuring Prostate Cancer, PET CT scan, 18F-DCFPyL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years and male.
Ability to understand the study and the willingness to sign a written informed consent document.
Histologically confirmed adenocarcinoma of the prostate.
PSA greater than 10, or Gleason ≥4+3, or clinical stage greater than or equal toT2c.
Plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer.
Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
No prior local therapy for prostate cancer (i.e., prostatectomy, radiotherapy, etc.).
Willing to comply with the procedural requirements of this protocol.

Exclusion Criteria:

Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
The subject has a condition or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study.
Primary small cell carcinoma of the prostate.
Participation in this study significantly delay the scheduled standard of care therapy.
Weighs greater than 350 lbs., or unable to fit within the imaging gantry.
The subject undergone prior local therapy for prostate cancer (i.e. prostatectomy, radiotherapy, etc.).
Currently receiving androgen deprivation therapy (ADT) or anti-androgen? Previous use of ADT is allowed IF the subject has been off ADT or anti-androgen for 3 months or more.

Sites / Locations

VA Greater Los AngelesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

Outcomes

Primary Outcome Measures

the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging

Secondary Outcome Measures

Full Information

NCT ID

NCT03852654

First Posted

February 21, 2019

Last Updated

February 21, 2019

Sponsor

Lida Jafari

Collaborators

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT03852654

Brief Title

18F-DCFPyL PET-CT Scan and Prostate Cancer

Official Title

A Novel 18F-DCFPyL PET-CT Scan for Diagnosis and Management of Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 22, 2018 (Actual)

Primary Completion Date

December 30, 2019 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lida Jafari

Collaborators

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging. Secondary Objectives: Frequency of the change in primary treatment plan after initial staging.

Detailed Description

This is a single arm Phase II clinical trial in Veterans with prostate cancer, no prior local therapy, who are at risk of having metastatic disease (PSA greater than 10, or Gleason Score greater than or equal to 4+3, or clinical stage greater than or equal to T2c). Veterans who are planned to undergo or have recently undergone conventional, routine care initial staging scans for prostate cancer (99mTc-MDP or NaF PET bone scan and diagnostic CT or MRI of pelvis) will also receive a 18F-DCFPyL PET-CT scan. The primary endpoint is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT scan identifies evidence of M1 disease at initial staging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer Adenocarcinoma

Keywords

Prostate Cancer, PET CT scan, 18F-DCFPyL

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

18F-DCFPyL

Intervention Description

Subjects with biopsy proven prostate cancer, no prior local therapy, and: PSA ≥ 10 ng/dl, or Gleason Sum ≥ 4+3, or clinical stage ≥cT2c Staging by 99mTc-MDP or NaF PET bone scan, and Diagnostic CT (pelvis) or MRI will undergo 18F DCFPyL PET CT scan.

Primary Outcome Measure Information:

Title

the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging

Time Frame

120 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years and male. Ability to understand the study and the willingness to sign a written informed consent document. Histologically confirmed adenocarcinoma of the prostate. PSA greater than 10, or Gleason ≥4+3, or clinical stage greater than or equal toT2c. Plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer. Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2. No prior local therapy for prostate cancer (i.e., prostatectomy, radiotherapy, etc.). Willing to comply with the procedural requirements of this protocol. Exclusion Criteria: Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection. The subject has a condition or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study. Primary small cell carcinoma of the prostate. Participation in this study significantly delay the scheduled standard of care therapy. Weighs greater than 350 lbs., or unable to fit within the imaging gantry. The subject undergone prior local therapy for prostate cancer (i.e. prostatectomy, radiotherapy, etc.). Currently receiving androgen deprivation therapy (ADT) or anti-androgen? Previous use of ADT is allowed IF the subject has been off ADT or anti-androgen for 3 months or more.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jafari Lida, M.D.

Phone

310 268 3583

lida.jafari@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Nicholas G Nickols, M.D., Ph.D.

Phone

310 268 3390

nicholas.nickols@va.gov

Facility Information:

Facility Name

VA Greater Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90073

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lida Jafari, M.D.

12. IPD Sharing Statement

Learn more about this trial

18F-DCFPyL PET-CT Scan and Prostate Cancer

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